Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer

Официальное название

Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer: A Randomised Controlled, Open-label, Phase 2 Trial

Обзор

For unresectable locally-advanced non-small cell lung cancer, chemoradiotherpay plus immunotherapy is recommended by PACIFIC trial. However, it is unclear whether surgery can provide survival benefit for patients with tumors initially unresectable transformed into resectable ones after chemoimmunotherapy. This trial aims to investigate the efficacy and safety of the therapeutic regimen of chemoimmunotherapy plus surgery.

Вмешательства

• Препарат Serplulimab
  Specified dose on specified days
• Препарат Carboplatin
  Specified dose on specified days
• Препарат Pemetrexed
  Specified dose on specified days
• Препарат Nab-paclitaxel
  Specified dose on specified days
• Препарат Liposomal paclitaxel
  Specified dose on specified days
• Процедура Surgery
  Patients with stage IIIB-IIIC non-small cell lung cancer are treated with nab-paclitaxel/pemetrexed plus carboplatin and serplulimab for 4 cycles. Those with downstaged and resectable tumors after chemoimmunotherapy are randomised into surgical treatment arm and radiotherapy arm, and those with tumors still unresectable after chemoimmunotherapy will receive non-surgical treatment in department of medical oncology in the third arm.
• Лучевая терапия Radiotherapy
  Patients with stage IIIB-IIIC non-small cell lung cancer are treated with nab-paclitaxel/pemetrexed plus carboplatin and serplulimab for 4 cycles. Those with downstaged and resectable tumors after chemoimmunotherapy are randomised into surgical treatment arm and radiotherapy arm, and those with tumors still unresectable after chemoimmunotherapy will receive non-surgical treatment in department of medical oncology in the third arm.

Первичные конечные точки

• Event-free survival (EFS) [Срок оценки: Up to 30 months]

Вторичные конечные точки (10)

• Objective response rate (ORR) [Срок оценки: Up to 4 months]
• Major pathologic response (MPR) [Срок оценки: up to 5 months]
• Progression-free survival (PFS) [Срок оценки: up to 60 months]
• Disease-free survival (DFS) [Срок оценки: up to 60 months]
• Overall survival (OS) [Срок оценки: up to 60 months]
• Duration of response (DOR) [Срок оценки: up to 60 months]
• Disease-control rate (DCR) [Срок оценки: up to 60 months]
• R0 rate [Срок оценки: up to 5 months]
• Severe adverse event (SAE) rate [Срок оценки: up to 6 months]
• Health related quality of life (HRQol) [Срок оценки: up to 5 months]

Критерии участия

Критерии включения

• The patient shall sign the Informed Consent Form.
• Aged 18 ≥ years.
• Histological or cytological diagnosis of NSCLC by needle biopsy, and stage IIIB-IIIC confirmed by imageological examinations (CT, PET-CT or EBUS).
• Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
• Life expectancy is at least 12 weeks.
• At least 1 measurable lesion according to RECIST 1.1.
• Patients with good function of other main organs (liver, kidney, blood system, etc.)
• Patients with normal lung function can tolerate surgery;
• Without systematic metastasis (including M1a, M1b and M1c);
• Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of Serplulimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
• Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of Serplulimab (whichever is later).

Критерии исключения

• Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
• Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
• With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
• Participants who are allergic to the test drug or any auxiliary materials;
• Participants with Interstitial lung disease currently;
• Participants with active hepatitis B, hepatitis C or HIV;
• Pregnant or lactating women;
• Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
• Participated in another therapeutic clinical study;
• Other factors that researchers think it is not suitable for enrollment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Pulmonary Hospital — Шанхай

Идентификаторы

NCT: NCT05766800 · LungMate-013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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